BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 871089 · Received May 18, 2007

    Report

    Report Number
    9616025-2007-00068
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Manufacturer
    SCANDINAVIAN EYEWEAR AB
    Product Code
    ---
    PMA / PMN Number
    K041005
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATMENT DATA FILES RELATED TO THE REPORTED EVENT WERE NOT AVAILABLE FOR REVIEW BY THE MFR. IT WAS NOTED THAT IN THE HOUR OF THE EXCESSIVE FLUID REMOVAL, THE MACHINE WAS REPORTED TO HAVE ALARMED THREE TIMES FOR INCORRECT WEIGHT CHANGE ALERTING THE USER OF THE DETECTED IMBALANCE. UPON INSPECTION, IT WAS DETERMINED THAT THE MACHINE PERFORMED TO MFR'S SPECIFICATIONS. IN ADDITION TO THIS MDR, A SEPARATE MDR WAS FILED ON THE PRISMASATE ON 05/03/2007 (MDR 1051129-2007-00007).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * --- SCANDINAVIAN EYEWEAR AB

    Patients

    Seq Age Sex Outcome Treatment
    1